PHARMACIST STEVE

Bayer Pharmaceuticals and Johnson & Johnson have prevailed in the first federal trial involving Xarelto. However, litigation over the blood thinner is far from concluded, as more than 18,000 Xarelto lawsuits remain pending in courts around the U.S.

Jury’s Decision Based on “Learned Intermediary Doctrine”

The trial, which came to a close last Wednesday in the U.S. District Court, Eastern District of Louisiana, was the first of four bellwether trials scheduled in a multidistrict litigation that includes more than 16,000 Xarelto lawsuits. The Plaintiff, 75-year-old Joseph Boudreaux, suffered a serious gastrointestinal bleed less than one month after he was prescribed Xarelto to prevent stroke. He alleged that the drug’s manufacturers failed to warn his prescribing physician that Xarelto could cause uncontrollable bleeding, pointing out that there is no approved antidote to reverse its anticoagulant effects in an emergency. By contrast, internal bleeding associated with an older blood thinner called warfarin can be stopped via the administration of vitamin K. During the trial, Mr. Boudreaux’s prescribing physician testified that he stood by his decision to prescribe Xarelto.  According to HarrisMartin.com, the jury found that the Defendants had not failed to provide adequate warnings to the doctor, leading them to conclude that the Plaintiff’s failure-to-warn claims were barred by the learned intermediary doctrine. This legal doctrine holds that a manufacturer’s duty to warn has been fulfilled so long as an “intermediary” medical professional has been adequately apprised of a drug’s risks.

18,000+ Xarelto Lawsuits Still to Be Decided

Xarelto was approved by the U.S. Food & Drug Administration (FDA) in October 2011 and has since become a top-seller for both Bayer and Johnson & Johnson. Xarelto generated sales of $3.24 billion last year for the Germany-based company, while Johnson & Johnson recorded $2.29 billion from its sales of the medication. However, plaintiffs pursuing Xarelto lawsuits claim that the companies’ success was the result of misleading marketing that wrongly positioned the medication as a superior alternative to warfarin.

While plaintiffs are no doubt disappointed by the outcome of the first Xarelto trial, the verdict has no bearing on any remaining lawsuits. This includes the more than 16,000 cases still pending in the federal multidistrict litigation, as well as nearly 1,400 that have been filed in a mass tort program now underway in Pennsylvania’s Philadelphia Court of Common Pleas. Each of these Xarelto lawsuits will need to be decided on their own, specific merits.

Meanwhile, bellwether trials will continue as scheduled in the federal multidistrict litigation. The Eastern District of Louisiana will convene the nation’s second Xarelto trial on May 30^th. Two other bellwether trials are scheduled to get underway later this summer in the U.S. District Court, Southern District of Mississippi, and the U.S. District Court, Northern District of Texas.